The present invention relates to a method for treating disease and alleviating pain associated with the lymphatic system in a living mammalian body. More particularly, the present invention relates to a noninvasive method for detecting and activating the lymphatic system wherein the method involves the generation of a pulsation detectable at the closest exterior body surface to an activated lymphatic area.
The lymphatic system is a subsidiary of the circulatory system that offers a route for the return of tissue fluid to the bloodstream. The system includes lymph capillaries that begin in tissue to collect tissue fluid, i.e., lymph. The capillaries eventually lead into lymphatic vessels which empty lymph into large veins above the heart. Along the pathway of the lymphatic vessels are specialized structures called lymph nodes. The lymph nodes serve two important purposesxe2x80x94as a filter to prevent the spread of infection and as a source of lymphocytes. In contrast to the cardiovascular system which forms a complete circuit, the lymphatic system is a one-way system.
Lymphatic capillaries are simple endothelial tubes that form a complex network in tissues. Beginning blindly, the capillaries may vary greatly in size ranging from a diameter of about a few microns to about a millimeter. Ordinarily, these capillaries do not contain valves. The network of capillaries is most dense in surface layers of the body, such as in the dermis of the skin and the mucosal layers of the digestive and respiratory system. Muscles and bones, for example, exhibit a lower density of lymphatic capillaries while no lymphatic capillaries are found in the central nervous system, meninges, epidermis, and eyeball. A special category of lymphatic capillaries extends as blind ends into the intestinal villi and are known as lacteals. Lacteals are connected to the thymus. During fat absorption from the intestine, the lymph within lacteals becomes milky in appearance and is called chyle.
The lymphatic capillaries convey lymph to larger lymph vessels (lymphatics) which resemble veins in structure but have thinner walls and more valves. The lymphatics also contain a large number of lymph nodes, usually about 600, at various intervals throughout the body. They are disposed in loose connective tissue between organs, the subcutaneous and subserous tissues, and in the submucosa of the digestive, respiratory, and urogenital tracts. Shallow lymphatics of the skin generally follow veins, while deeper lymphatics generally follow arteries. The lymphatics serve to deliver lymph throughout the body and return proteins to the cardiovascular system when they leak out of blood capillaries. Lymphatics also transport fats from the gastrointestinal tract to the blood. Lymph flow is effected by the milking action of the muscle tissues of the body on the adjacent or contained lymphatic capillaries and vessels. Valves insure that lymph is conveyed in the correct direction.
Lymphatic nodes are typically bean-shaped collections of lymphatic tissue interposed in the course of lymphatic vessels. The tissue of the node is enclosed in a strong fibroelastic capsule. Trabeculae originate from the capsule and into the node to divide the node into several compartments. A network of reticular fibers with reticulo-endothelial cells extends from the trabeculae to all parts of the node. The cortex, i.e., the outer part of the node, contains closely packed masses of lymphocytes and lymph follicles. Several afferent lymphatic vessels enter the node on its convex surface and release lymph into the sinuses of the node. As the lymph slowly moves through the node, reticulo-endothelial cells filter out foreign particles such as bacteria via phagocytosis. As a result, foreign particles are prevented from entering the bloodstream. In addition, lymphocytes produced in the germinal centers of the lymph follicles are introduced into the lymph stream. Efferent lymphatic vessels at the node""s hilum located on the nodes"" concave surface allow lymph to leave the node to continue toward the venous system. Valves disposed in the afferent and efferent lymphatic vessels insure proper lymph flow direction. Blood vessels interface with the node at the hilum.
In sum, lymph nodes provide a key component for the proper immunological function of mammals. In humans, lymph nodes can be found in a high concentration in the face and neck, the arm pits, the thoracic cavity, the intestines and groin, the elbows, and the knees. Many different types of lymphocytes are produced by these nodes in the human body. Some lymphocytes (T cells) destroy infectious agents directly or indirectly by releasing various substances. Other lymphocytes (B cells) differentiate into plasma cells that secrete antibodies against foreign substances to help eliminate them. The spleen, thymus and tonsils are the lymphatic organs which produce B-cells, T-cells, and lymphocytes, respectively, and, with antibodies, complete the lymphatic system immunologic defenses. Importantly for cancer patients, lymphatic tissue functions in surveillance and defense against foreign cells, microbes, and cancer cells and other pathogens, as is discussed infra.
A compromised lymphatic system is associated with disease and pain as many lymph nodes and other components of the lymphatic system are located at or near nerve endings. Lymphedema, for example, is a disorder of the lymphatic system wherein excess lymph is accumulated. Such undesirable accumulation causes swelling in different part throughout the entire body including, but not limited to, the arm(s) and/or leg(s). Generally, lymphedema can develop when lymph vessels are missing or impaired, when lymph vessels are damaged, or when lymph nodes are removed. In essence, lymphedema results when the amount of lymph exceeds local lymphatic transport capacity and an abnormal amount of protein-rich fluid collects in the tissues of the effected area. It is important to emphasize that if left untreated, this stagnant protein-rich fluid causes tissue channels to increase in size and number, reduces oxygen availability in the transport system, interferes with wound healing, and provides a medium in which bacteria can incubate and proliferate, resulting in lymphangitis. The reduction of oxygen will cause lymph nodes to restrict the flow resulting from lymphatic drainage. Moreover, such swelling may cause or aggravate hernias.
In addition, cancer is often associated with lymphedema. Many cancer patients undergo surgery or radiation therapy to eliminate the cancerous growth. Surgery may remove lymph nodes, particularly if cancerous cells are identified in the lymph nodes, and lymphedema may occur as a result. In addition, radiation therapy will lead to an edema of irradiated soft tissues and lymphedema of any irradiated lymphatic tissue. Lymphedema is generally the more serious of these two side effects, because of the importance of the patient""s lymphatic system to continued immune function and general health. However, repetition of radiation therapy can both further and prolong lymphedema, frequently making it a progressively more severe side effect. In addition, chemotherapy following surgery may also worsen lymphedema if administered to an already affected area.
Symptomatically, edema and lymphedema may be particularly pronounced in the upper torso due to radiation treatment of cancers of the head and neck, lungs, breast and the lymphatic system. Strong and frequent upper body radiation may cause fibrosis of the jaw and neck with excessive fibroblast deposition, thus virtually immobilizing patients and requiring such patients to be fed with a straw. Fibrosis of the upper arm may also occur with continuing radiation treatment thereby limiting the range of motion for the affected limb(s). In addition, new tumors may emerge in the edematous limbs and other portions of the lymphatic system because tumor cells, given the reduced lymph flows, lymphocyte production and ion exchange in these radiation-induced immunologically compromised edematous body parts, may take root and grow.
Lymphedema is treated through a variety of regimens with varying degrees of success. Such regimens often involve compression therapy or mechanical action. For example, U.S. Pat. No. 5,672,148 to Maunier describes a hydraulic device for lymphatic drainage and massage of the human body. This reference is directed to a device that can transmit a large variety of pressure ranges over any portion of the body with pressure profiles adapted to effect desired lymphatic drainage. It may be possible to improve lymphatic circulation, as described in U.S. Pat. No. 5,940,888 to Sher, by wearing a lymphatic circulation enhancer attached under the side panels of a woman""s brassier. The enhancer comprises a lattice framework having a plurality of raised protuberances projecting outward therefrom. Such lymphatic circulation enhancers are described to provide relief from constriction of the lymph system by a woman""s bra. Such devices suffer from the limitation that non-surface portions of the lymphatic system, e.g., the portion within the rib cage, are unaffected through device use.
Pharmacologically active agents may also effect lymph node drainage or activity. For example, U.S. Pat. No. 5,753,237 to Daynes et al. describes a method of augmenting immunological responses by administering a vaccine comprising an immunizing agent and a vaccine adjuvant of dihydroepiandrosterone sulfate (DHEAS) or 16xcex1-bromo-DHEAS. It is described that such administration of the adjuvant and the immunizing agent may drain a lymph node. In addition, U.S. Pat. No. 5,595,743 to Wu describes a process for preparing an herbal medicine. The process involves forming a mass from raw material, finely grinding the mass to make average size of suspended particles less than 50 xcexcm, hydrolyzing the ground material by using a particular multi-enzyme system, and sterilizing the hydrolyzed material. By using poria, pinellia tube, pilose asiabell root, immature bitter orange, green tangerine orange peel, atrac tylodes rhizome, fresh ginger, oldenlandia and loniccera japonica flow in a proper proportion as raw material, the herbal medicine produced by this method is described by Wu as capable of inhibiting edema and improving cell activity of T lymphocyte cell.
Lymphedema may also be treated by application of an interferential microcurrent electrical waves. For example, U.S. Pat. No. 5,817,138 to Suzuki describes a method for treating a patient having lymphedema to improve lymphatic flow. The method involves providing multiple pairs of electrodes, each pair of electrodes connected to an electrical source defining a channel to provide a micro current of electricity across patient tissue, and positioning four or more pairs of electrodes on the patient, each electrode proximal to a center of lymph nodes. Then, a controlled current from about 20 xcexcA to about 200 xcexcA is provided to each channel at a frequency of up to 300 Hz. In addition, a first frequency is provided to at a first channel and a second frequency is provided to another channel to create an interferential wave form. Finally, pulsed electrical currents are passed through the patient""s body using a wave form envelope with a mandatory pause between pulses. This reference also describes incorporation of the electrodes in gloves such that massaging movement may be applied during application of the micro currents.
Beside lymphedema, the lymphatic system is associated with autoimmune diseases such as rheumatoid arthritis (RA). In RA, as with other autoimmune diseases, a patient becomes immunologically sensitive to an antigenic material in his or her own body. The primary symptom of RA is inflammation of the synovial membrane, wherein the membrane thickens and synovial fluid accumulates. The resulting pressure causes pain and tenderness. As lymphocytes and macrophages learn to react to these unknown xe2x80x9cself-antigens,xe2x80x9d they accumulate in the target organ, i.e., the synovial tissue, a hydrated sack which functions as a cushion and a lubricated bearing between the joints of the skeleton. The macrophages release small amounts of nitrous acid. Together with released free radicals and nitrosylated tyrosine residues of various proteins and polypeptides, these materials are strongly cytotoxic and produce a pannus of necrosis within the synovium, which adheres to the articular cartilage. Pannus formation sometimes erodes the cartilage completely. When the cartilage is destroyed, fibrous tissue joins the exposed bone ends. The tissue then ossifies and fuses the joint so that it is immovable, leading to a failure of the targeted joint, thereby crippling the patient in use of the afflicted limb. It is described that such arthritis may be treated by injecting a preparation comprising a pressure treated autoimmune specific T cell composition. See U.S. Pat. No. 4,996,1984 to Cohen et al. Such a composition may be prepared using T lymphocyte mitogen activated lymph node cells.
The lymphatic system has also been linked with obesity control. U.S. Pat. No. 5,391,143 to Kensey describes an implantable system for effective removal of fat or other components carried by the lymphatic system from a body by draining some lymphatic fluid from the body. The reference describes that the system may remove fat continually over a protracted period of time from the lymphatic fluid.
It is evident that current methods for effecting healing that involve the lymphatic system require mechanical action, interferential electrical microcurrents, pharmacologically active agents, and/or invasive procedures. Thus, there is a need to provide a new noninvasive method to treat conditions resulting from lymphatic disorders.
Accordingly, it is an object of the present invention to overcome the above-mentioned disadvantages of the prior art by providing a new method that noninvasively detects and activates the lymphatic system in treating disease and alleviating pain without side or after effects that characterize many other lymphatic treatments.
It is another object of the invention to provide a method to drain a portion of a lymphatic system of a living mammalian body to promote proper functioning of immunological response to pathogens.
Additional objects, advantages and novel features of the invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention.
In one aspect, then, the present invention generally relates a non-invasive method for alleviating a disorder associated with a lymph node in a living mammalian body. The method calls for physical contact with a stimulation source to be provided simultaneously at the closest exterior body surface to the lymph node and at an opposing body surface. Once in place, the stimulation source transfers energy to the closest exterior body surface so as to induce localized pulsations that characterize the activation of the lymph node. In certain instances, the energy transfer stimulates a diseased lymph node. For optimal results, energy is continuously transferred until the localized pulsations substantially subside. This non-invasive method is particularly suited for use without anesthesia and applicable to a non-surface lymph node, i.e., one that is located is closer to an artery than a vein.
In another aspect, the invention relates to the method as above, wherein the stimulation source has a substantially constant temperature in a range from about 30xc2x0 C. to about 45xc2x0 C. and contacting the closest exterior body surface with the source. In addition, the simulation may cause the simulated area to increase in temperature.
In still another aspect, the invention relates to the method as above, wherein the closest exterior body surface contacts a source surface adapted to conform to the closest exterior body surface. In addition, the opposing body surface may also contact another source surface adapted to conform to the opposing body surface. The source surface may comprise a flexible and/or organic flexible material.
In a further aspect, the invention relates to the method as above, wherein contact is provided at a time to an area of about 1 cm2 to about 400 cm2 of the closest exterior body surface.
In a still further aspect, the invention relates to the method as above wherein non-thermal energy is transferred to the closest exterior body surface. The non-thermal energy may be electrical or magnetic.
In another aspect, the invention relates to the method as above, wherein the living mammalian body having the disorder is human. The living mammalian body may exhibit edema such as lymphedema, cancer, auto-immune diseases such rheumatoid arthritis or obesity. In addition, the living mammalian body may have undergone other treatment for cancer such as radiation therapy, chemotherapy or surgery.
In still another aspect, the invention relates to the method as above, wherein the stimulation source is the hand or other body part of a human individual. Preferably, the individual establishes physical contact between the closest exterior body surface and his or her hand or fingertip. In addition, contact may be established between the opposing body surface and the other hand of the individual. Preferably, the individual can detect the localized pulsations through tactile sensations and/or as sounds.
In a further aspect, the invention generally relates to a noninvasive method for draining a portion of a lymphatic system in a living mammalian body. The method involves providing physical contact with a stimulation source simultaneously at an exterior body surface that exhibits a symptom due to blockage of the portion of the lymphatic system and at an opposing body surface with respect to the exterior body surface. Once contact is established, energy is transferred from the stimulation source to the exterior body surface to induce localized pulsations that characterize lymphatic activation and drainage. The energy may be magnetic, electrical, possibly thermal or some other type of energy. Energy is transferred to the closest exterior body surface until lymphatic healing is complete.
In a still further aspect, the invention generally relates to a noninvasive method for alleviating discomfort such a pain associated with a malfunctioning portion of a lymphatic system in a living mammalian body. The method involves providing physical contact with a stimulation source simultaneously at the closest exterior body surface to a healthy portion of the lymphatic system and at an opposing body surface with respect to the exterior body surface. Once such contact is established, energy is transferred from the stimulation source to the closest exterior body surface to induce localized pulsations that characterize the activation and drainage of the malfunctioning portion of the lymphatic system.